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Company · US

Oxford Performance Materials

FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2019. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	2
KKY	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction	2
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	1
MQP	Spinal Vertebral Body Replacement Device	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jul 3, 2019	K190915	OsteoFab Suture Anchors Oxford Performance Materials, Inc.	MBI
Jul 27, 2018	K180064	OsteoFab Patient Specific Cranial Device Oxford Performance Materials, Inc.	GXN
Jul 20, 2016	K161052	OsteoFab Patient Specific Facial Device Oxford Performance Materials, Inc.	KKY
Jul 10, 2015	K142005	SpineFab Vertebral Body Replacement (VBR) System Oxford Performance Materials	MQP
Jul 28, 2014	K133809	OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE Oxford Performance Materials	KKY
Feb 7, 2013	K121818	OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE Oxford Performance Materials	GXN

Latest recalls

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.

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